Tattooed Skin and Health

J. Serup, N. Kluger, W. Bäumler, J., Serup, N., Kluger, W., Bäumler, P. Itin, G. B. E. Jemec, P., Itin, G.B.E., Jemec

• Publisher: S. Karger
• Year: 2015
• Print ISBN: 9783318027761
• eBook ISBN: 9783318027778
• Topic: Medicine
• Subtopic: Dermatology

With about 10–20% of the adult population in Europe being tattooed, there is a strong demand for publications discussing the various issues related to tattooed skin and health. Until now, only a few scientific studies on tattooing have been published. This book discusses different aspects of the various medical risks associated with tattoos, such as allergic reactions from red tattoos, papulo-nodular reactions from black tattoos as well as technical and psycho-social complications, in addition to bacterial and viral infections. Further sections are dedicated to the composition of tattoo inks, and a case is made for the urgent introduction of national and international regulations. Distinguished authors, all specialists in their particular fields, have contributed to this publication which provides a comprehensive view of the health implications associated with tattooing. The book covers a broad range of topics that will be of interest to clinicians and nursing staff, toxicologists and regulators as well as laser surgeons who often face the challenge of having to remove tattoos, professional tattooists and producers of tattoo ink.

Ingredients, Chemical Analysis and Safety of Marketed Tattoo Ink Stock Products

Serup J, Kluger N, Bäumler W (eds): Tattooed Skin and Health.
Curr Probl Dermatol. Basel, Karger, 2015, vol 48, pp 136-141 (DOI: 10.1159/000369647)

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Chemical Purity and Toxicology of Pigments Used in Tattoo Inks

Henrik Petersen · Dirk Lewe

MT.DERM GmbH, Berlin, Germany

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Abstract

The safety of tattoo inks has obviously increased in Europe since the existence of European Union Resolution ResAP(2008)1, which resulted in the improved quality control of pigment raw materials due to the definition of impurity limits that manufacturers can refer to. High-performance pigments are mostly used in tattoo inks, and these pigments are supposed to be chemically inert and offer high light fastness and low migration in solvents. However, these pigments were not developed or produced for applications involving long-term stay in the dermis or contact with bodily fluids. Therefore, these pigments often do not comply with the purity limits of the resolution; however, it is required that every distributed tattoo ink does not contain aromatic amines and not exceed the limits of heavy metals or polycyclic aromatic hydrocarbons. Current toxicity studies of pigments underline that no ecotoxicological threat to human health or to the environment should be expected. However, the pigment as well as its impurities and coating materials must be considered. In order to evaluate the safety of pigments according to their impurities, two different validated sample preparation methods are necessary: (1) simulation of their long-term stay in the bodily fluid of the dermis and (2) simulation of cleavage due to laser removal or ultraviolet exposure. The development of standardized, validated and well-adapted methods for this application has to be part of prospective efforts. Concerning legislation, it might be appropriate that the first regulative approaches be based on those of cosmetics.

© 2015 S. Karger AG, Basel

Introduction

Tattooing of humans has a long history and was independently developed in different areas of the world. In the early beginning, tattooing was often used for spiritual signs or for martial reasons, but currently, it is used more as body art to create individual appearance or to demonstrate the belonging to specific groups. In Germany, 10% of the population is tattooed, and because of its rising popularity, it can be expected that this number will increase within the next years. The results of surveys of a group of tattooed people pointed out that 67.5% of the people suffered skin problems like itching, burning or redness and that 6.6% reported persistent symptoms, skin papules or granuloma [1]. During studies on a red pigment, it was shown that up to 9.42 mg/cm² of pigment, 2.53 mg/cm² on average, is applied into the skin, depending on the technique and experience of the tattooist [2, 3]. In the early stages, people dispersed carbon black from campfires or pigments from other natural sources into water in order to get a pigment paste. With industrialization in the 19th century, companies started to synthesize pigments and to produce tons of raw materials to be used by the growing industries for applications like automotive coatings and interior or exterior paints. The development of new pigments for the special demands of several industrial applications is the reason for the current presence of a huge variety of different chemical structures and modifications. Therefore, pigment manufacturers sometimes offer the same pigment class for more than one application (plastics, coatings, printing, textiles). Some pigments that are in accordance with the European Union (EU) Regulation on cosmetics are also available. However because the tattoo business is small and not profitable compared to other industries, like cosmetics or industrial coatings, the pigment manufacturer doesn't make any efforts to develop and produce any specific pigments for this application. Obviously, these pigments often do not comply with the purity limits for heavy metals, harmful aromatic amines and others that are prescribed in the EU resolution ResAP(2008)1 on tattoo inks because the pigments are produced for other applications, where higher limits are tolerated. This is why tattoo ink manufacturers have to carefully choose their supplier and conduct accurate and repeating quality control on the purchased pigments. Authorities’ interests in the safety of tattoo inks have increased in the past few years, and there are ongoing discussions about how the safety of pigments can be accurately evaluated. This article will give an overview about the pigments used in tattoo inks and the problems that manufacturers are facing because of the impurities and regulatory situation. This article will also give insight into quality control from the manufacturer's point of view.

Overview of Used Pigments

The selection of pigments in tattoo or permanent make-up (PMU) ink can differ because of the demand for more natural colors in PMU, but for more bright and shiny colors for tattoo inks. Generally, pigments in water-based inks have to offer high light fastness and stability against bleeding due to the permanent stay of the inks in the dermis because migration of particles in the skin or ultraviolet-induced cleavage of pigments has to be avoided. In table 1, a list of pigments that are often used in tattoo and PMU inks is shown.

Mostly, the pigments belong to the group of high performance pigments, which are supposed to be chemically inert and are distinguished with high light fastness, weather stability and low-migration properties in solvents. These properties make these pigments adequate for tattoo inks because they achieve long-lasting colors in the skin.

Current Regulatory Situation in the European Union

The first EU Resolution ResAP(2003)2 dealing with tattoo and PMU products was launched in 2003 and was replaced by the actual EU Resolution ResAP(2008)1 in 2008. Resolution ResAP(2008)1 is the most detailed regulatory document to point out requirements and criteria for the safety of tattoos and PMU. This resolution is a recommendation and has to be transferred into local law, but up to now, just a few EU countries have done so. All other countries do not entirely or adequately regulate this kind of application or the used products. Manufacturers should be encouraged to make data like the composition and the toxicological data of the substances of their product available to the competent authorities [4]. This resolution also lists the aromatic amines that should not be present in tattoos and PMU products because of their potentially harmful carcinogenic, mutagenic, reprotoxic and sensitizing properties. Some examples of aromatic amines that are not allowed in tattoo and PMU products are benzidine, 4-chloroaniline, 6-methoxy-m-toluidine or 2-naphthylamine. In addition, a negative list, or list of forbidden colorants, is also included in this resolution. The limit for polycyclic aromatic hydrocarbons (PAHs) is set at 0.5 ppm, and the limit for benzene-a-pyrene is 5 ppb. Table 2 shows an overview of the limits for aromatic amines, PAHs and heavy metals.

Table 1. A choice of pigments in tattoo and PMU inks [11]

Table 2. Overview of the limits and methods for detection according to ResAP(2008)1

Element or compound	Limit, ppm	Detection method
Aromatic amines	absence	eGC-MS/LC-MS after extraction in phosphate buffer or HCl [4]
PAH	0.5	no method described
Benzene-a-pyrene	5	no method described
As, Se, Sb, Pb	2	no method described
Ba, Sn, Zn	50	no method described
Co, Cu (soluble)	25	no method described
Cd, Cr (IV), Hg	0.2	no method described
Ni	as low as technically achievable	no method described

Table 2 also shows that the current resolution is obviously still not sufficient to accurately maintain the toxicological safety of pigments in tattoo and PMU products. For nickel, no specific limits exist, and it is not clear what ‘technically achievable limit’ really means. Furthermore, an analysis method has only been suggested for the detection of aromatic amines. For PAHs or heavy metals, how to analyze the pigments, so that their safety can be evaluated correctly, has not been recommended, yet. Confusion and misunderstandings between manufacturers and authorities happens, if both are analyzing the products in different ways, because this leads to different results which cannot be compared. In the future, it will be necessary to harmonize the analytical methods for tattoo and PMU products and their related limits; otherwise, it will be impossible for manufacturers to perform and maintain suitable quality controls.

Impurities and Toxicological Aspects

Recent toxicological analysis of high performance pigments found that there is no expected ecotoxicological threat to human health and the environment [5]. These pigments are usually inert and insoluble, which results in minimal ecotoxicological properties. However, the permanent contact of the pigments with human cells o...

Table of contents

• Cover Page
• Front Matter
• The Tattooed and the Social Environment
• The Practise of Tattooing
• Tattoos and Adverse Events
• Manufacturing, Materials and Properties of Marketed Tattoo Ink Stock Products
• Ingredients, Chemical Analysis and Safety of Marketed Tattoo Ink Stock Products
• Regulation of and Intervention in the Tattoo Business
• Author Index
• Subject Index